The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation.

Gynecologic Disease Clinical Trial

Official title:

The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425484
• Other study ID #: USM/JEPeM/kk/23010129
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: Universiti Sains Malaysia
• Contact: Rhendra Hardy Mohd Zain
• Phone: +6097676104
• Email: rhendra[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare effectiveness between epidural combined with TAP block versus epidural alone in gynaecology operation participant .The main question[s] it aims to answer are:

• what is the pain score for both groups

• what is the requirement of epidural infusion between the 2 groups Participants will be given general anesthesia for the operation with the epidural insertion prior to induction. Patient will be randomized into epidural plus TAP block or epidural alone for the study. The US TAP block will be given at the end of operation prior to extubation.

Researchers will compare pain score, epidural infusion requirment between the two groups.

Description:

The research is a prospective randomized control study. It is blinded study as accessor is blinded whereby the acute pain service (APS) team will be reviewing patient postoperatively.

Study size of 46 subjects based on repeated measure ANOVA between factor , alpha value 0.05% with 80% power study, a dropout 10%. Divided into 2 groups ; Group E - epidural alone, Group T - epidural plus bilateral US TAP block.

Perioperatively, epidural catheter will be inserted then induction for general anesthesia given. Intraoperatively anesthesia maintain with inhalation agent. Prior to extubation, bilateral TAP block is provided using portable US guidance. At this location, the 3 layers of anterior abdominal wall is visualized for the truncal block. Post operatively, participant will be given epidural cocktail bupivacaine 0.1% + fentanyl 2mcg/ml infusion for next 24hrs.

The APS team will review patient post operatively in ward and all data will be recorded. Participation of patient's during study is approximately 2 days duration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective major laparotomy gynaecology procedure.

• Age 18 years and above

• ASA I, II, III

Exclusion Criteria:

• Prolonged INR

• Allergic to LA

• History of chronic pain

• Psychological disorder/addict to opioid or benzodiazepine

• Any contraindication for epidural or TAP block procedure

• Pregnancy

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease

Intervention

Other:
• Bilateral US TAP block
epidural plus bilateral US guided TAP block

Locations

Country	Name	City	State
Malaysia	Universiti Sains Malaysia	Kubang Kerian	Kelantan

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (6)

Ganapathy S, Sondekoppam RV, Terlecki M, Brookes J, Das Adhikary S, Subramanian L. Comparison of efficacy and safety of lateral-to-medial continuous transversus abdominis plane block with thoracic epidural analgesia in patients undergoing abdominal surgery: A randomised, open-label feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):797-804. doi: 10.1097/EJA.0000000000000345. — View Citation

Huepenbecker SP, Cusworth SE, Kuroki LM, Lu P, Samen CDK, Woolfolk C, Deterding R, Wan L, Helsten DL, Bottros M, Mutch DG, Powell MA, Massad LS, Thaker PH. Continuous epidural infusion in gynecologic oncology patients undergoing exploratory laparotomy: Th — View Citation

Iyer SS, Bavishi H, Mohan CV, Kaur N. Comparison of Epidural Analgesia with Transversus Abdominis Plane Analgesia for Postoperative Pain Relief in Patients Undergoing Lower Abdominal Surgery: A Prospective Randomized Study. Anesth Essays Res. 2017 Jul-Sep;11(3):670-675. doi: 10.4103/0259-1162.206856. — View Citation

Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31. — View Citation

Wu Y, Liu F, Tang H, Wang Q, Chen L, Wu H, Zhang X, Miao J, Zhu M, Hu C, Goldsworthy M, You J, Xu X. The analgesic efficacy of subcostal transversus abdominis plane block compared with thoracic epidural analgesia and intravenous opioid analgesia after rad — View Citation

Yoshida T, Furutani K, Watanabe Y, Ohashi N, Baba H. Analgesic efficacy of bilateral continuous transversus abdominis plane blocks using an oblique subcostal approach in patients undergoing laparotomy for gynaecological cancer: a prospective, randomized, triple-blind, placebo-controlled study. Br J Anaesth. 2016 Dec;117(6):812-820. doi: 10.1093/bja/aew339. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score between epidural plus bilateral TAP block and epidural alone	To compare the pain score between 2 groups (epidural with bilateral TAP block) and epidural alone for gynaecology operation.	Post operatively, until day 2 post operation.
Secondary	To compare the epidural infusion requirement between the 2 groups ( Group T and Group E)	To compare the postoperative epidural infusion requirement between bilateral US guided TAP block plus epidural versus epidural alone.	Post operatively, until day 2 post operation.
Secondary	To evaluate time of early mobilization between 2 groups ( Group T and Group E)	To evaluate time taken for early mobilization between group Epidural with TAP block and epidural alone after the operation .	Post operatively, until day 2 post operation.